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Guselkumab achieves 88.8% IGA 0/1 at week 16 in Chinese patients with plaque psoriasisTrial shows guselkumab helps Chinese patients with plaque psoriasis

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Key Takeaway
Note guselkumab's high efficacy for PASI 90 and IGA 0/1 in Chinese patients with moderate-to-severe plaque psoriasis.

This Phase 4 randomized controlled trial enrolled 327 Chinese patients with moderate-to-severe plaque psoriasis to evaluate the efficacy and safety of guselkumab. The study compared guselkumab (100 mg subcutaneous injection at weeks 0 and 4, then every 8 weeks) against a placebo-to-guselkumab regimen (placebo at weeks 0, 4, and 12, followed by guselkumab at weeks 16, 20, 28, 36, and 44).

At week 16, the guselkumab group achieved significantly higher rates of PASI 90 (82.4% vs. 2.0%, P <0.001) and IGA 0/1 (88.8% vs. 7.1%, P <0.001) compared to the placebo group. At week 48, results for both PASI 90 (79.2% vs. 80.2%) and IGA 0/1 (82.4% vs. 86.3%) were comparable between the guselkumab and placebo-to-guselkumab groups.

Safety data for the first 16 weeks showed adverse events in 41.9% of the guselkumab group versus 39.1% in the placebo group. Serious adverse events were lower in the guselkumab group (0.9%) compared to the placebo group (5.5%).

A primary limitation of this study is the limited data from randomized controlled trials specifically in the Chinese population. However, the trial supports the use of guselkumab as an effective treatment for moderate-to-severe plaque psoriasis in this demographic.

How this fits prior evidence

How this fits prior evidence: This finding extends the evidence for guselkumab in plaque psoriasis, which was previously noted to rank highly for PASI 75 and PASI 90. It also provides specific data for a Chinese patient population, complementing the established efficacy of guselkumab in patients with psoriatic arthritis.

Living with plaque psoriasis can mean dealing with persistent, itchy, and uncomfortable skin patches. A recent trial looked at how the medication guselkumab helps patients manage this condition. The study focused on 327 Chinese patients with moderate to severe cases of the disease.

Researchers found that patients who received guselkumab saw much better results early on. By week 16, over 82% of those on the medication reached a high level of skin clearance, compared to only 2% in the group that started with a placebo. The study also showed a favorable safety profile, with very few serious side effects reported during the first 16 weeks.

While the results were very strong at the 16-week mark, the study notes that data from randomized trials specifically in the Chinese population is still limited. However, the findings suggest that guselkumab is a highly effective option for those seeking to clear their skin and manage their symptoms.

What this means for you:
Guselkumab showed high effectiveness and a favorable safety profile for Chinese patients with plaque psoriasis.

Common questions

How effective is guselkumab for plaque psoriasis?

The trial showed that guselkumab was highly effective. By week 16, 82.4% of patients taking the medication achieved a high level of skin clearance (PASI 90), compared to only 2% in the placebo group. These results were consistent with a favorable safety profile for patients with moderate to severe cases.

Is guselkumab safe for patients with psoriasis?

The study reported a favorable safety profile for guselkumab. During the first 16 weeks, only 0.9% of patients in the guselkumab group experienced serious adverse events, which was lower than the 5.5% reported in the placebo group. You should discuss these results with your doctor to see if it is right for you.

How long did the study follow the patients?

The study followed patients for a total of 48 weeks. While the most significant difference between the guselkumab and placebo groups was seen at week 16, the results remained comparable between the two groups at the 48-week mark. This provides a longer look at how the treatment performs over time.

Study Details

Study typeRct
Sample sizen = 419
EvidenceLevel 2
Follow-up1.8 mo
PublishedSep 2026
View Original Abstract ↓
BACKGROUND: Guselkumab is effective in treating moderate-to-severe plaque psoriasis; however, data from randomized controlled trials in the Chinese population are limited. This study evaluated and verified the efficacy and safety profile of guselkumab in Chinese patients with moderate-to-severe plaque psoriasis. METHODS: This was a randomized, double-blind, placebo-controlled, phase 4 study. Patients with moderate-to-severe plaque psoriasis were randomized 2:1 to the guselkumab group (guselkumab 100 mg by subcutaneous injection at weeks 0 and 4, then every 8 weeks thereafter through week 44) or the placebo-to-guselkumab group (placebo at weeks 0, 4, and 12, then guselkumab at weeks 16, 20, 28, 36, and 44). Coprimary efficacy endpoints were the proportion of patients achieving Psoriasis Area and Severity Index (PASI) 90 response and the proportion of patients achieving Investigator's Global Assessment (IGA) 0/1 response at week 16. RESULTS: Among the 419 patients screened for eligibility between August 25, 2021, and July 21, 2022, 327 patients were enrolled. All 327 randomized patients (mean age, 41.5 [standard deviation, 12.7] years; 259 [79.2%] men) were treated and included in the analyses. At week 16, 103/110 patients assigned to the placebo group at baseline started guselkumab treatment. Most patients completed the study (210 in guselkumab group and 101 in placebo-to-guselkumab group). Significantly higher proportions of patients with guselkumab achieved PASI 90 (82.4% vs. 2.0%; P <0.001) and IGA score 0/1 (88.8% vs. 7.1%; P <0.001) compared with placebo at week 16. At week 48, response rates were maintained in the guselkumab group (PASI 90: 79.2%; IGA 0/1: 82.4%) and increased in the placebo-to-guselkumab group (PASI 90: 80.2%; IGA 0/1: 86.3%). During the first 16 weeks, the incidence of adverse events was comparable between groups (41.9% guselkumab vs. 39.1% placebo) and the incidence of serious adverse events was low (0.9% vs. 5.5%), respectively. CONCLUSION: Guselkumab was highly effective and displayed a favorable safety profile for the treatment of moderate-to-severe plaque psoriasis in Chinese patients. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT04914429.
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